Safety and Efficacy of DCB Therapy for de Novo Lesions Under the Guidance of QFR in CHD Patients (UNIQUE-DCB-I Study )
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary Heart Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
The current study is designed as a multicenter, randomized and prospective study aiming to evaluate the safety and efficacy of drug balloon therapy for de novo lesions in patients with CHD under the guidance of QFR compared with DES implantation. Based on previous study, the incidence rate of target...
The current study is designed as a multicenter, randomized and prospective study aiming to evaluate the safety and efficacy of drug balloon therapy for de novo lesions in patients with CHD under the guidance of QFR compared with DES implantation. Based on previous study, the incidence rate of target lesion failure is 5%-10% in patients with CHD undergoing DES implantation. And in the investigators study the expected incidence rate of target lesion failure is up to 5.0 % in patients with CHD after treatment with DCB. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 220 patients with CHD were required, and with 110 patients per group as a ratio of 1:1 randomization.
Tracking Information
- NCT #
- NCT04104854
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Fei Ye, MD Nanjing First Hospital, Nanjing Medical University
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